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The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alfapump system | Experimental | The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alfapump system | Device | The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of serious adverse events related to the device and its implantation. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the overall requirement for large volume paracentesis | Assess the overall requirement for large volume paracentesis by investigation of:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Kamath, MD | Mayo Clinic, Rochester, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical | San Francisco | California | United States | |||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31999044 | Derived | Wong F, Bendel E, Sniderman K, Frederick T, Haskal ZJ, Sanyal A, Asrani SK, Capel J, Kamath PS. Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump. Liver Transpl. 2020 May;26(5):651-661. doi: 10.1002/lt.25724. Epub 2020 Mar 22. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 14, 2022 | |
| Reset | Nov 8, 2022 |
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| 12 months |
| Nutritional status | Nutritional status o evaluate changes in serum prealbumin | 12 months |
| Evaluate patient quality of life | Evaluate patient quality of life
| 12 months |
| Overall survival | 12 months |
| Rochester |
| Minnesota |
| United States |
| Baylor University Healthcare System | Dallas | Texas | United States |
| University of Virginia | Charlottesville | Virginia | United States |
| VCU Medical Centre | Richmond | Virginia | United States |
| Toronto General Hospital | Toronto | Ontario | M5G 1Z5 | Canada |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 14, 2022 | Nov 8, 2022 |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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